The tubing used to subcutaneously deliver insulin from a Tandem Diabetes Care pump is among the latest devices to land in the FDA’s hot seat. Unomedical A/S began a recall of some of its VariSoft ...

The Food and Drug Administration has categorized Unomedical’s recall of VariSoft infusion sets as a Class I event. Unomedical, working with its partner Tandem Diabetes Care, contacted customers last ...

Unomedical A/S, a maker of single-use medical devices, is pulling about 130,000 insulin infusion products from the market because it might detach mid-infusion, according to the FDA. Nearly 130,700 ...

The infusion set is an important part of the pump. Infusion sets should only be used once and usually need to be changed within 2 or 3 days. Infusion sets are the parts of an insulin pump that go on ...